The inhaled therapy for the maintenance treatment of COPD combines bronchodilator and non-steroidal anti-inflammatory activities in one molecule.
RT’s Three Key Takeaways:
- Ohtuvayre is the first inhaled COPD therapy to combine bronchodilator and non-steroidal anti-inflammatory activities in a single molecule.
- The FDA’s approval of Ohtuvayre is based on phase 3 ENHANCE trials, which showed significant clinical benefits and good tolerance in patients with moderate to severe COPD.
- Ohtuvayre is scheduled for a US launch in the third quarter of 2024.
The US Food and Drug Administration (FDA) has approved Ohtuvayre (ensifentrine) for the maintenance treatment of chronic obstructive pulmonary disease (COPD) in adult patients.
Ohtuvayre is the first inhaled product with a novel mechanism of action available for the maintenance treatment of COPD in more than 20 years, according to the drug’s developer, Shanghai-based Verona Pharma plc.
Ohtuvayre is a first-in-class selective dual inhibitor of the enzymes phosphodiesterase 3 and phosphodiesterase 4 that combines bronchodilator and non-steroidal anti-inflammatory effects in one molecule. Ohtuvayre is delivered directly to the lungs through a standard jet nebulizer without the need for high inspiratory flow rates or complex hand-breath coordination.
Phase 3 ENHANCE Trials and Clinical Benefits
The US approval of Ohtuvayre was based on data including the phase 3 ENHANCE trials, the results of which were published in the American Journal of Respiratory and Critical Care Medicine. In the ENHANCE trials, Ohtuvayre demonstrated clinical benefits both alone and when used with other maintenance therapies. Ohtuvayre was well-tolerated in a broad population of subjects with moderate to severe COPD.
“The approval of Ohtuvayre is a significant advance in COPD care, and we believe Ohtuvayre’s novel profile can change the treatment paradigm for COPD,” says David Zaccardelli, PharmD, president and chief executive officer of Verona Pharma, in a release. “We plan to launch Ohtuvayre in the third quarter 2024, ensuring Ohtuvayre is available to help the millions of patients who still experience daily COPD symptoms.”
Future Applications and Global Impact
Mark Lotter, founder and CEO of Nuance Pharma, adds in a release, “We are pleased to see ensifentrine’s approval with FDA and the planned commercial launch in the US, and we are excited about ensifentrine’s potential to redefine the COPD treatment globally as the first-in-class novel therapy.”
Ensifentrine has potential applications for development in non-cystic fibrosis bronchiectasis, cystic fibrosis, asthma and other respiratory diseases, according to a release from Verona Pharma.
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